BRPI0715247B8 - forma farmacêutica com camada de separação de múltiplas camadas, seu uso e seu processo de produção - Google Patents

forma farmacêutica com camada de separação de múltiplas camadas, seu uso e seu processo de produção

Info

Publication number
BRPI0715247B8
BRPI0715247B8 BRPI0715247A BRPI0715247A BRPI0715247B8 BR PI0715247 B8 BRPI0715247 B8 BR PI0715247B8 BR PI0715247 A BRPI0715247 A BR PI0715247A BR PI0715247 A BRPI0715247 A BR PI0715247A BR PI0715247 B8 BRPI0715247 B8 BR PI0715247B8
Authority
BR
Brazil
Prior art keywords
layer
water
dosage form
production process
separating layer
Prior art date
Application number
BRPI0715247A
Other languages
English (en)
Portuguese (pt)
Inventor
Lizio Rosario
Roth Erna
Petereit Hans-Ulrich
Original Assignee
Evonik Roehm Gmbh
Roehm Gmbh
Evonik Degussa Gmbh
Evonik Operations Gmbh
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Evonik Roehm Gmbh, Roehm Gmbh, Evonik Degussa Gmbh, Evonik Operations Gmbh filed Critical Evonik Roehm Gmbh
Publication of BRPI0715247A2 publication Critical patent/BRPI0715247A2/pt
Publication of BRPI0715247B1 publication Critical patent/BRPI0715247B1/pt
Publication of BRPI0715247B8 publication Critical patent/BRPI0715247B8/pt

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0007—Effervescent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5015—Organic compounds, e.g. fats, sugars
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medicinal Preparation (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Laminated Bodies (AREA)
BRPI0715247A 2006-07-27 2007-03-19 forma farmacêutica com camada de separação de múltiplas camadas, seu uso e seu processo de produção BRPI0715247B8 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE102006035549.0 2006-07-27
DE102006035549A DE102006035549A1 (de) 2006-07-27 2006-07-27 Arzneiform mit mindestens zweischichtiger Trennschicht
PCT/EP2007/052549 WO2008012115A1 (de) 2006-07-27 2007-03-19 Arzneiform mit mehrschichtiger trennschicht

Publications (3)

Publication Number Publication Date
BRPI0715247A2 BRPI0715247A2 (pt) 2012-12-25
BRPI0715247B1 BRPI0715247B1 (pt) 2020-05-19
BRPI0715247B8 true BRPI0715247B8 (pt) 2022-07-05

Family

ID=38123804

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0715247A BRPI0715247B8 (pt) 2006-07-27 2007-03-19 forma farmacêutica com camada de separação de múltiplas camadas, seu uso e seu processo de produção

Country Status (14)

Country Link
US (1) US7871643B2 (pl)
EP (1) EP2046304B1 (pl)
JP (1) JP5675100B2 (pl)
KR (1) KR101390079B1 (pl)
CN (1) CN101484149B (pl)
BR (1) BRPI0715247B8 (pl)
CA (1) CA2659026C (pl)
DE (1) DE102006035549A1 (pl)
ES (1) ES2441953T3 (pl)
IL (1) IL195223A (pl)
MX (1) MX2009000964A (pl)
PL (1) PL2046304T3 (pl)
SI (1) SI2046304T1 (pl)
WO (1) WO2008012115A1 (pl)

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DE102004036437A1 (de) 2004-07-27 2006-03-23 Röhm GmbH & Co. KG Multipartikuläre Arzneiform für wenig lösliche Wirkstoffe, sowie ein Verfahren zur Herstellung der Arzneiform
DE102004059792A1 (de) * 2004-12-10 2006-06-14 Röhm GmbH & Co. KG Multipartikuläre Arzneiform, enthaltend mucoadhaesiv formulierte Nukleinsäure-Wirkstoffe, sowie ein Verfahren zur Herstellung der Arzneiform
DK2152250T3 (da) 2007-05-07 2019-12-09 Evonik Degussa Gmbh Faste doseringsformer, der omfatter et enterisk overtræk, med accelereret lægemiddelfrigivelse
WO2008146178A2 (en) * 2007-05-30 2008-12-04 Wockhardt Research Centre A novel tablet dosage form
US9192578B2 (en) * 2008-08-20 2015-11-24 Board Of Regents, The University Of Texas System Hot-melt extrusion of modified release multi-particulates
EP2358360B1 (en) * 2008-11-18 2016-09-14 UCB Biopharma SPRL Prolonged release formulations comprising an 2-oxo-1-pyrrolidine derivative
BR112012021445B8 (pt) 2010-02-25 2022-07-05 Evonik Roehm Gmbh formulação farmacêutica ou neutracêutica, e uso de um agente promotor de biodisponibilidade
CN103082295A (zh) * 2011-11-01 2013-05-08 江苏江山制药有限公司 一种含b族维生素的三层泡腾片的制备工艺
CN102599494A (zh) * 2011-11-01 2012-07-25 江苏江山制药有限公司 一种含维生素c的三层泡腾片的制备工艺
US9301920B2 (en) 2012-06-18 2016-04-05 Therapeuticsmd, Inc. Natural combination hormone replacement formulations and therapies
US8633178B2 (en) 2011-11-23 2014-01-21 Therapeuticsmd, Inc. Natural combination hormone replacement formulations and therapies
US10806740B2 (en) 2012-06-18 2020-10-20 Therapeuticsmd, Inc. Natural combination hormone replacement formulations and therapies
US10806697B2 (en) 2012-12-21 2020-10-20 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
US20150196640A1 (en) 2012-06-18 2015-07-16 Therapeuticsmd, Inc. Progesterone formulations having a desirable pk profile
US20130338122A1 (en) 2012-06-18 2013-12-19 Therapeuticsmd, Inc. Transdermal hormone replacement therapies
DE102012221848A1 (de) * 2012-11-29 2014-06-05 Robert Bosch Gmbh Abgabe- und Dosiersystem, insbesondere von Substanzen in mikrofluidischen Systemen, sowie Verfahren und Kartusche mit dem Abgabe- und Dosiersystem
US10471072B2 (en) 2012-12-21 2019-11-12 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
US10537581B2 (en) 2012-12-21 2020-01-21 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
US11246875B2 (en) 2012-12-21 2022-02-15 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
US9180091B2 (en) 2012-12-21 2015-11-10 Therapeuticsmd, Inc. Soluble estradiol capsule for vaginal insertion
US11266661B2 (en) 2012-12-21 2022-03-08 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
US10568891B2 (en) 2012-12-21 2020-02-25 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
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WO2014129568A1 (ja) * 2013-02-22 2014-08-28 ゼリア新薬工業株式会社 腸溶錠
US9617259B2 (en) 2013-03-14 2017-04-11 Chdi Foundation, Inc. Histone deacetylase inhibitors and compositions and methods of use thereof
EP3145489A1 (en) 2014-05-22 2017-03-29 TherapeuticsMD, Inc. Natural combination hormone replacement formulations and therapies
US20170042806A1 (en) 2015-04-29 2017-02-16 Dexcel Pharma Technologies Ltd. Orally disintegrating compositions
US10328087B2 (en) 2015-07-23 2019-06-25 Therapeuticsmd, Inc. Formulations for solubilizing hormones
KR102408645B1 (ko) * 2015-12-24 2022-06-14 (주)휴온스 안정성이 증가된 에스오메프라졸 함유 이중코팅정 조성물 및 이의 제조방법
US10588864B2 (en) 2016-03-11 2020-03-17 Gateway Pharmaceuticals LLC Pharmaceutical compositions for colon-specific delivery
WO2017173044A1 (en) 2016-04-01 2017-10-05 Therapeuticsmd Inc. Steroid hormone compositions in medium chain oils
WO2017173071A1 (en) 2016-04-01 2017-10-05 Therapeuticsmd, Inc. Steroid hormone pharmaceutical composition
DE102016109017B4 (de) * 2016-05-17 2018-06-14 Wincor Nixdorf International Gmbh Kistenstapelsystem und Kistenstapelvorrichtung
US10076494B2 (en) 2016-06-16 2018-09-18 Dexcel Pharma Technologies Ltd. Stable orally disintegrating pharmaceutical compositions
CN106622051B (zh) * 2016-12-29 2019-08-13 厦门金达威维生素有限公司 一种微胶囊流化交联方法
ES3006512T3 (en) * 2017-11-17 2025-03-18 Evonik Operations Gmbh Process for preparing a coated hard shell capsule
CN116270513A (zh) * 2018-01-09 2023-06-23 南京三迭纪医药科技有限公司 一种包含固定剂量adhd非兴奋剂和adhd兴奋剂的复方口服药物剂型
WO2019217286A1 (en) 2018-05-07 2019-11-14 Prana Biosciences Inc Metaxalone formulations
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Also Published As

Publication number Publication date
KR101390079B1 (ko) 2014-05-19
KR20090038438A (ko) 2009-04-20
PL2046304T3 (pl) 2014-03-31
MX2009000964A (es) 2009-02-04
IL195223A0 (en) 2009-08-03
EP2046304A1 (de) 2009-04-15
US7871643B2 (en) 2011-01-18
JP2009544639A (ja) 2009-12-17
US20080026051A1 (en) 2008-01-31
ES2441953T3 (es) 2014-02-07
IL195223A (en) 2015-07-30
CA2659026A1 (en) 2008-01-31
CA2659026C (en) 2014-05-13
BRPI0715247A2 (pt) 2012-12-25
CN101484149B (zh) 2015-12-02
WO2008012115A1 (de) 2008-01-31
SI2046304T1 (sl) 2014-02-28
EP2046304B1 (de) 2013-10-09
JP5675100B2 (ja) 2015-02-25
CN101484149A (zh) 2009-07-15
DE102006035549A1 (de) 2008-01-31
BRPI0715247B1 (pt) 2020-05-19

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Legal Events

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B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]

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B06T Formal requirements before examination [chapter 6.20 patent gazette]
B06A Patent application procedure suspended [chapter 6.1 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
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B16C Correction of notification of the grant [chapter 16.3 patent gazette]

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B25D Requested change of name of applicant approved

Owner name: ROEHM GMBH (DE)

B25G Requested change of headquarter approved

Owner name: ROEHM GMBH (DE)

B25A Requested transfer of rights approved

Owner name: EVONIK DEGUSSA GMBH (DE)

B25D Requested change of name of applicant approved

Owner name: EVONIK OPERATIONS GMBH (DE)

B21F Lapse acc. art. 78, item iv - on non-payment of the annual fees in time

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B24J Lapse because of non-payment of annual fees (definitively: art 78 iv lpi, resolution 113/2013 art. 12)

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